Status:
COMPLETED
Dose Escalation Study With QLT0074 for Benign Prostatic Hyperplasia
Lead Sponsor:
QLT Inc.
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
Phase:
PHASE1
PHASE2
Brief Summary
The primary objective of this study is to assess the safety and tolerance of transurethral photodynamic therapy (PDT) with QLT0074. Secondary objectives are: 1. To determine if transurethral PDT wit...
Detailed Description
This will be a multicenter, uncontrolled, dose escalation, exploratory study in subjects with symptomatic BPH. Six study centers are planned. Each subject will receive a fixed dose of QLT0074 (0.4 mg...
Eligibility Criteria
Inclusion
- Twenty-seven men with symptomatic BPH despite adequate drug therapy and who are candidates for surgical or minimally invasive treatment will be enrolled in the study.
- Subjects must have an AUA SI \>13, Qmax between 5 and 15 mL/sec, and a urethral treatment length between 30 and 65 mm (defined as the length of the urethra between the bladder neck and the edge of the verumontanum distal to the bladder).
Exclusion
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00077012
Start Date
March 1 2003
End Date
May 1 2005
Last Update
May 23 2012
Active Locations (7)
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1
Raymond Fay, MD, Inc
San Francisco, California, United States, 94108
2
George Washington University Medical Center
Washington D.C., District of Columbia, United States, 20037
3
Advanced Research Institute Inc
New Port Richey, Florida, United States, 34652
4
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572